Background
Young men who have sex with men (YMSM) have high HIV incidence and challenges with PrEP adherence. Point-of-care (POC) urine tenofovir (TFV) testing permits real-time objective adherence monitoring at a low cost. A prior study with PrEP-using women in Kenya demonstrated improved long-term adherence when women had motivational interviewing (MI)-informed drug-level feedback using the POC test in the clinic. We adapted and pilot tested a 2-session, MI-informed intervention with POC self-testing and remote counseling.
Methods
Participants (age<30; n=49) who reported daily oral PrEP (F/TDF or F/TAF) use were recruited remotely from the Grindr application and randomized 2:1 to a 2 session MI-informed POC drug-level feedback counseling intervention delivered remotely by psychologists versus standard of care over a 3-month period. Urine POC tests were mailed to participants and self-administered before each session, informing the counseling. Self-collected hair samples were analyzed for TFV at baseline and 3 months using liquid chromatography/tandem mass spectrometry. GEE models analyzed the change in hair TFV levels over time comparing the intervention and control groups.
Results
Overall, the participants (n=49; 31 intervention/18 control) had a median age of 26 (IQR: 23-29) years; 30% were Hispanic, 26% were Black; and 46% used F/TAF. Of 31 intervention participants, 100% successfully self-administered the urine test and 100% reported the intervention was somewhat/very acceptable. Over the 3 months of the intervention, there was a 0.01 ng/mg increase in hair TFV levels in the intervention group when compared to the control group (95% CI: 0.00-0.18; p=0.04). This degree of change in hair TFV levels in the intervention group translates to ~1-2 more PrEP tablets per week. Among those with <4 doses/week adherence at baseline, 6 of 8 of the intervention participants increased above 4 doses/week compared to 0 of 4 participants in the control group.
Conclusions
In a diverse sample of YMSM using daily oral F/TDF or F/TAF PrEP, a pilot RCT of a telehealth MI-informed POC urine TFV testing intervention demonstrated preliminary efficacy for biologically verified increases in long-term adherence, assessed via hair TFV levels. Given the low-cost of the POC test, the remote nature of the intervention, and increasing use of telehealth to provide PrEP care, this approach could be scaled nationally and implemented outside of in-person clinic settings if more definitive RCTs provide evidence of efficacy.
Table or Figure
